Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT01545505 Statut inconnu

Titre

Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

Type

Interventional

Pathologie

Troubles de stress post-traumatique
Troubles de stress traumatique

Phase

N/A

Promoteur

Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)

Date de début

octobre 2012

Date de fin

juillet 2014

Dernière mise à jour

29 juin 2024

Résumé

Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.

Détail

Voir le détail One of the great challenges in Psychotraumatology is the high risk (20-40%) of post-traumatic stress disorder (PTSD) relapse, which markers remain understudied. Identification of these markers is of particular interest for the development of strategies to prevent relapse. Based on clinical and experimental data, it appears that (i) the so-called residual clinical symptoms (such as sleep disturbance, irritability) and (ii) the neuropsychological dysfunctions (cognitive difficulties), persisting after remission, may constitute markers of PTSD relapse. Moreover, all of these potential markers have also been linked with dysfunctions, persisting or reoccurring, in the prefrontal cortex after remission. The main objective of this study is to identify these clinical and neuropsychological markers of PTSD relapse in children and their families. The secondary objective is to demonstrate the link between prefrontal dysfunctions and relapse. This longitudinal study will include 4 experimental groups: - 30 children with PTSD - 30 children with past PTSD (children in remission) - 30 parents of children with PTSD - 30 parents of children with past PTSD The first visit is planned during the symptomatic phase (T0). The second visit (T1) is planned at the end of the symptomatic phase (or 6 months later T0). The last visit is planned 3-months after T1. The psychological assessment will include: A structured interview with a psychiatrist An assessment of PTSD symptoms (IES-R, CPTS-RI for children) An assessment of the co-morbidity (STAI C and CDI for children, STAI A-B, BDI for adults). An evaluation of the social life (EAS for children and SAS-SR for adults). The neuropsychological assessment will include: An evaluation of the attentional treatment (Go-No / go and visual search) An evaluation of executive functions (TMT A and B) A brief evaluation of the IQ (items memory of figures, matrix and resemblance) An evaluation of the memory (Grober and Buschke) Tests include an adult and children versions that are validated. All studies will be conducted at the Nice University Hospital, Tours University Hospital and Toulouse University Hospital. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de TOURS - 37044 - Tours - France		En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de NICE - 06000 - Nice - France	Michel BENOIT, M.D., PhD	En recrutement	Contact (sur clinicalTrials)
CHU de TOULOUSE - 31059 - Toulouse - France		Recrutement non commencé	Contact (sur clinicalTrials)
Fondation Lenval - 06000 - Nice - France	florence Askenazy, M.D.	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

For children

Inclusion Criteria:

- Children (9/18 years)

- Patients who have lived a traumatic event (physical assault and road accident) and
who have a PTSD.

- French speaker.

- Participants must sign the informed consent and they must be affiliated to the
social insurance.

Exclusion Criteria

- Children who have a neurological pathology.

- Children who have brain damage or brain-injured

- Subject having participated in a biomedical research in three months preceding the
inclusion

Critère de non inclusion

NCT01545505 - Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

Informations générales
Etablissements
Critères
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